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Demonstrated efficacy against RSV-LRTD for patients aged 60 years and older1

82.6% efficacy demonstrated in first occurrence of RSV-associated LRTD in patients ≥60 years of age (primary endpoint; incidence rate per 1,000 person-years: 1.0 vs. 5.8 for placebo; 96.95% CI: 57.9–94.1)1*

  • At the time of the primary efficacy analysis, study participants had been followed for the development of RSV-associated LRTD for up to 10 months (median of 6.7 months). 

* The primary endpoint for vaccine efficacy was defined as the first occurrence of RT-PCR-confirmed RSV-A and/or B-associated LRTD with an onset from 15 days after vaccination.

In patients with ≥1 comorbidity of interest (secondary endpoint), 94.6% (incidence rate per 1,000 person-years: 0.4 vs. 6.6 for placebo; 95% CI: 65.9–99.9) In patients with ≥1 comorbidity of interest (secondary endpoint), 94.6% (incidence rate per 1,000 person-years: 0.4 vs. 6.6 for placebo; 95% CI: 65.9–99.9)

Relative risk reduction versus placebo (96.95% CI for overall; 95% for all subgroups) for vaccine efficacy is derived based on Poisson model adjusted by age categories and regions.

Comorbidities of interest:1

INFECTED LUNGS ICON

Asthma, COPD, or any chronic respiratory/pulmonary disease

ICON OF A FAILING HEART

Chronic heart failure

ICON OF 2 BLOOD DROPLETS LABELLED 1 AND 2

Diabetes mellitus type 1 or type 2

ICON OF A DISEASED LIVER

Advanced liver disease

ICON OF DISEASED KIDNEYS

Advanced renal disease

COPD = chronic obstructive pulmonary disease; LRTD = lower respiratory tract disease.

Demonstrated efficacy against LRTD caused by RSV-A or RSV-B (secondary endpoints)1

84.6% efficacy demonstrated in first occurrence of RSV-A-associated LRTD (incidence rate per 1,000 person-years: 0.3 vs. 1.9 for placebo; 95% CI: 32.1–98.3) 84.6% efficacy demonstrated in first occurrence of RSV-A-associated LRTD (incidence rate per 1,000 person-years: 0.3 vs. 1.9 for placebo; 95% CI: 32.1–98.3)
80.9% efficacy demonstrated in first occurrence of RSV-B-associated LRTD (incidence rate per 1,000 person-years: 0.7 vs. 3.8 for placebo; 95% CI: 49.4–94.3) 80.9% efficacy demonstrated in first occurrence of RSV-B-associated LRTD (incidence rate per 1,000 person-years: 0.7 vs. 3.8 for placebo; 95% CI: 49.4–94.3)

Study design: AReSVi-0061,2

GRAPH OF THE STUDY DESIGN FOR A CLINICAL STUDY. ADULTS 60 YEARS OF AGE AND OLDER WERE RANDOMLY PLACED IN EITHER A PLACEBO GROUP OR A GROUP RECEIVING AREXVY. THE STUDY BEGAN IN MAY 2021 AND LASTED THROUGH 2 RSV SEASONS, UNTIL 2024. GRAPH OF THE STUDY DESIGN FOR A CLINICAL STUDY. ADULTS 60 YEARS OF AGE AND OLDER WERE RANDOMLY PLACED IN EITHER A PLACEBO GROUP OR A GROUP RECEIVING AREXVY. THE STUDY BEGAN IN MAY 2021 AND LASTED THROUGH 2 RSV SEASONS, UNTIL 2024.
  • Ongoing, Phase 3, placebo-controlled, randomized, observer-blind clinical study conducted in adults ≥60 years of age in 17 countries from Northern and Southern Hemispheres, including Canada
  • Patient population:
    • Adults 60 years of age and older with pre-existing, chronic, stable disease, with or without specified treatment, such as diabetes, hypertension, or cardiac disease, were allowed to participate in the study if considered by the investigator as medically stable at the time of vaccination.
  • Primary population for efficacy analysis included patients receiving 1 dose of AREXVY (n=12,466) or placebo (n=12,494) and who did not report an RSV-confirmed acute respiratory infection (ARI) prior to Day 15 after vaccination

RSV-associated LRTD was defined based on the following criteria1

LRTD: ≥2 lower respiratory symptoms or signs (including ≥1 lower respiratory sign for ≥24 hours) OR ≥3 lower respiratory symptoms for ≥24 hours

Lower respiratory symptoms included: Lower respiratory signs included:
  • New or increased:
    • sputum
    • cough
    • dyspnea (shortness of breath)
  • New or increased wheezing
  • Crackles/rhonchi
  • Respiratory rate ≥20 respirations/min
  • Low or decreased oxygen saturation (O2 saturation <95% or ≤90% if baseline is <95%)
  • Need for oxygen supplementation
SPEECH BUBBLES ICON

Start the conversation about RSV risk with your patients aged 60+ years

Older adults aged ≥60 years may receive a single dose of RSV vaccine, using shared clinical decision-making.3 

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ICON OF A PERSON AND A PIECE OF PAPER

Discover AREXVY safety profile 

The safety profile of AREXVY in adults aged 60 years and older was evaluated in Study AReSVi-006.1

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References:

  1. AREXVY Product Monograph. GlaxoSmithKline Inc.
  2. Papi A, et al. Respiratory syncytial virus prefusion F protein vaccine in older adults. NEJM 2023;388:595–608.
  3. Melgar M, et al. Use of respiratory syncytial virus vaccines in older adults: recommendations of the Advisory Committee on Immunization Practices—United States, 2023. Morb Mortal Wkly Rep 2023;72:793–801.

Trademarks are owned by or licensed to the GSK group of companies.

©2024 GSK Group of companies or its licensor.

104605 | 07/24

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